BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04025

    MDR report key: 3201874 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04025
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K033975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ACCORDING TO THE INFORMATION ON THE RECEIVED DOCUMENTS IT HAS BEEN NOTICED THAT THE HEAD OF THE SCREWS ARE BROKEN. SINCE THE CONCERNED SCREWS WERE RETURNED FOR ANALYSIS BUT THE EXACT LOT NUMBER IS NOT KNOWN THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED AND WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. NEVERTHELESS, YOU MAY BE ASSURED THAT WE HAVE TAKEN NOTE OF YOUR INPUT, THIS REPORT HAS BEEN ENTERED IN OUR MARKET VIGILANCE SYSTEM AND THE CORRESPONDING STATISTICAL DATA WILL BE KEPT UNDER TRENDING.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS (B)(4) ADDITIONAL CODES: JEY, MQN. DEVICE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT UNDERWENT SURGERY FOR FILING A JAW TUMOR AMELOBLASTOMA PLEXIFORM, AND WAS IMPLANTED WITH RECONSTRUCTION PLATES OF THE MATRIXMANDIBLE SYSTEM IN (B)(6) 2012. ABOUT 2 MONTHS AGO, THE PATIENT PRESENTED SWELLING IN THE CHIN REGION. RADIOGRAPHY SHOWS FOUR TITANIUM SCREWS WITH BROKEN HEADS. REVISION SURGERY IS PLANNED FOR AN UNKNOWN DATE TO REMOVE AND REPLACE THE BROKEN SCREWS. THIS REPORT IS FOR FOUR UNKNOWN SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302554 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention